Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has enteredinto settlement and license agreements with Wyeth, now part of Pfizer,relating to Venlafaxine Hydrochloride (HCl) Extended Release (ER) Capsules,37.5 mg, 75 mg and 150 mg, the generic version of Wyeth’s Effexor XR@Capsules, a treatment for major depressive disorder. Pursuant to the license agreement, Mylan will be granted a non-exclusivelicense to the relevant patents that would permit Mylan to launch VenlafaxineHCl ER Capsules in the U.S. on or after June 1, 2011, or earlier in limitedcircumstances. Additional details of the agreement remain confidential.Venlafaxine HCl ER Capsules had U.S. sales of approximately $2.9 billionfor the same strengths for the 12 months ending Sept. 30, according to IMSHealth. Currently, Mylan has 129 abbreviated new drug applications (ANDAs)pending U.S. Food and Drug Administration approval representing $85 billion inannual brand sales, according to IMS. Thirty-seven of these pending ANDAs arepotential first-to-file opportunities, representing $19.2 billion in annualbrand sales, according to IMS.
